Quality Assurance Engineer

2 weeks ago

Singapore Career Edge Asia Pte Ltd Full time

$5500 + AWS + VB + allowance

5 working days, Mon - Fri, normal office hours

Location: North

**Responsibilities**
- Assures product quality requirements are fulfilled in accordance with the Plant’s quality system and in compliance with corporate policies, customer, regulatory and statutory requirements.
- Provides quality engineering expertise in Catheter & Transducer production line (pulmonary Artery and Central Venous Catheter and Accessories & Transducers) and other related manufacturing operations and key Plant initiatives.
- Drives opportunities for continual improvement and drives QE section initiatives in respective function so as to support departmental goals in alignment to Plant’s vision, objectives and shared values.
- Perform effective failure analysis and provide investigation report to customer in a timely manner.
- Manage the quality control inspection and ensure good quality of product release.
- Support Internal Audit program to ensure Plant’s Quality System complies with 21 CFR Part 820 - Quality Systems Regulation, ISO13485 / MDSAP and any other applicable standards & government regulations including effectiveness review of system for continual improvement
- Provide technical support for the department and cross functional teams in achieving QE section initiatives and plant objectives.
- Manages, leads, and develops QC inspectors.

**Requirements**:

- At least 2 - 3 years of relevant work experience in a manufacturing environment, two of which should be in quality related areas
- Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Regulations, ISO 13485 / MDSAP Quality System Standard and ISO 14971 Risk Management
- Certified Six-Sigma Black/Green Belt and Validation practitioner is a plus
- Certified Quality Engineer and Certified Lead Assessor will be an advantage

**Please connect us via LinkedIn as follows for efficient messaging**:
**Do Join us at TELEGRAM by searching “CAREER EDGE JOB OPPORTUNITIES” to receive fast job alert**

Attn: Jace Tay (Registration No.: R1331152)

CAREER EDGE ASIA PTE LTD
EA Licence Number: 13C6678

**More Information**:

- **Salary Offer **$4000-$5500

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